The importance of publication guidelines for substudies

We discuss above some guidelines with respect to sub-studies which are an integral part of the main trial. However, within multi-centre trials, it maybe that individual centres will want to publish data on their own patients within the trial - for example they may have collected additional data over and above the trial requirements, or simply wish to report historical series. It is useful to state clearly, in the protocol, guidelines on the nature and timing of such publications. The key aim is to avoid a situation where early publication of a subset of data could prejudice the publication of the full trial results. A standard paragraph from MRC protocols states 'the results from individual centres will be analysed together and published as soon as possible. No individual centre may publish data on their own patients which are relevant to the main trial results until the main study report has been published.' Another role of the independent trial monitoring/steering committee (see Section 8.10) maybe to advise in situations where it may not immediately be clear that the subset results 'are relevant to the main study results.'

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